厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.266294262925630696278562578628600.30
210.296267662567626220.13
单位质量响应值RSD%判断
6126.716085.710.48数据可信
供试品溶液-5122601批-非奈利酮-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16819-681910.04312.4845.0610.0412.4845.06
29228-922813.59113.59
315740-1574023.18123.18
46390-63909.4119.41
57619-761911.22111.22
65052-50527.4407.44
10min137240-3724054.84555.716.4854.9655.856.55
238052-3805256.04156.19
341149-4114960.60260.86
434043-3404350.13750.24
539639-3963958.37858.50
636836-3683654.25054.33
15min147560-4756070.04470.182.4970.7670.942.59
247713-4771370.26971.04
349494-4949472.89273.82
445847-4584767.52168.18
548056-4805670.77471.55
647239-4723969.57170.26
20min152124-5212476.76576.961.2178.2678.491.29
252833-5283377.81079.36
352575-5257577.43079.17
451153-5115375.33576.75
552789-5278977.74579.30
652050-5205076.65678.11
30min158252-5825285.79085.871.4488.1488.261.48
259224-5922487.22289.64
358570-5857086.25988.86
456780-5678083.62385.87
558173-5817385.67488.10
658819-5881986.62588.94
45min159083-5908387.01488.961.3990.3292.311.42
260802-6080289.54692.93
361166-6116690.08293.64
459729-5972987.96691.14
560528-6052889.14292.52
661126-6112690.02393.30
60min161199-6119990.13191.041.9894.4095.382.00
261901-6190191.16595.55
362526-6252692.08596.65
459736-5973687.97692.13
563233-6323393.12697.49
662311-6231191.76896.04
90min164098-6409894.40095.010.7499.67100.360.75
264087-6408794.38499.78
364974-6497495.690101.27
464408-6440894.85799.99
564291-6429194.684100.09
665212-6521296.041101.33
120min162193-6219391.59593.281.5697.9299.681.55
263284-6328493.20199.65
363528-6352893.561100.21
462273-6227391.71297.90
564722-6472295.319101.77
664017-6401794.281100.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限163347-6334793.29493.411.05100.63100.851.03
263023-6302392.817100.30
363407-6340793.382101.07
462622-6262292.22699.43
563582-6358293.640101.15
664590-6459095.125102.53
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.226465996470756476306464566458566467230.11
215.286455376450976453170.05
单位质量响应值RSD%判断
42491.6642232.790.44数据可信
供试品溶液-5122601批-厄贝沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165577-655779.2889.1927.889.299.1927.87
285564-8556412.11912.12
387311-8731112.36612.37
445662-456626.4676.47
556614-566148.0198.02
648554-485546.8776.88
10min1299171-29917142.37442.168.9542.4842.268.99
2303681-30368143.01243.15
3341795-34179548.41148.55
4274867-27486738.93139.00
5300705-30070542.59142.68
6265543-26554337.61137.69
15min1417884-41788459.18859.084.0659.7659.654.13
2418358-41835859.25559.87
3448056-44805663.46164.14
4409618-40961858.01758.52
5411311-41131158.25758.82
6397598-39759856.31556.81
20min1480023-48002367.98968.212.2369.2269.432.32
2487459-48745969.04270.31
3498240-49824070.56971.95
4481079-48107968.13969.29
5476215-47621567.45068.66
6466365-46636566.05567.17
30min1559102-55910279.19079.981.7881.1881.961.86
2573847-57384781.27883.32
3580539-58053982.22684.39
4559358-55935879.22681.13
5555460-55546078.67480.63
6559726-55972679.27881.13
45min1589951-58995183.55985.792.2686.4388.662.28
2607770-60777086.08389.02
3629300-62930089.13292.21
4609095-60909586.27089.06
5595710-59571084.37587.21
6602281-60228185.30588.04
60min1618266-61826687.56988.841.7891.3692.661.83
2625460-62546088.58892.49
3647209-64720991.66995.74
4616675-61667587.34491.09
5631356-63135689.42393.19
6624408-62440888.43992.12
90min1653538-65353892.56593.651.6097.3398.461.60
2654258-65425892.66797.55
3676212-67621295.777100.86
4672436-67243695.24299.96
5651375-65137592.25997.02
6659374-65937493.39298.06
120min1638974-63897490.50292.251.3696.3098.111.38
2645198-64519891.38497.30
3664603-66460394.132100.28
4653732-65373292.59398.37
5655339-65533992.82098.61
6650072-65007292.07497.78
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1651505-65150592.27792.451.1399.0899.331.14
2643375-64337591.12698.05
3663397-66339793.962101.16
4656324-65632492.96099.76
5645979-64597991.49498.32
6655621-65562192.86099.59
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.266279762684627786289962918628150.16
210.296322563345632850.14
单位质量响应值RSD%判断
6122.326150.150.33数据可信
供试品溶液-5122901批-非奈利酮-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12418-24183.5444.1764.263.544.1764.28
21923-19232.8182.82
32380-23803.4883.49
41639-16392.4022.40
52182-21823.1983.20
66529-65299.5689.57
10min132931-3293148.26145.7011.6748.3045.7411.70
233362-3336248.89348.92
331327-3132745.91145.95
424630-2463036.09636.12
529944-2994443.88443.92
634902-3490251.15051.26
15min146921-4692168.76466.932.3269.3467.482.37
245869-4586967.22267.80
346451-4645168.07568.62
444297-4429764.91965.35
544499-4449965.21565.74
645981-4598167.38768.06
20min150768-5076874.40275.330.7775.7476.630.77
251212-5121275.05376.37
351890-5189076.04677.35
451380-5138075.29976.45
551480-5148075.44676.69
651693-5169375.75877.18
30min155730-5573081.67484.401.7583.8486.541.68
258156-5815685.22987.38
357752-5775284.63786.79
457709-5770984.57486.56
558706-5870686.03688.12
657503-5750384.27286.54
45min159068-5906886.56688.461.5289.6491.531.40
260518-6051888.69191.79
360120-6012088.10891.20
461845-6184590.63693.56
560625-6062588.84891.89
659987-5998787.91391.11
60min162008-6200890.87591.520.9094.9195.570.80
262823-6282392.06996.16
362437-6243791.50395.57
462880-6288092.15396.09
562957-6295792.26696.29
661570-6157090.23394.41
90min163719-6371993.38294.681.6898.4399.761.55
264071-6407193.89899.01
364659-6465994.76099.85
465167-6516795.504100.46
566442-6644297.373102.43
663574-6357493.17098.35
120min163409-6340992.92894.401.1099.01100.521.01
264146-6414694.008100.16
364881-6488195.085101.22
465124-6512495.441101.46
565038-6503895.315101.45
663880-6388093.61899.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限163266-6326692.71894.261.1899.83101.441.08
264951-6495195.188102.39
364334-6433494.284101.48
465331-6533195.745102.82
564270-6427094.190101.39
663768-6376893.454100.71
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.226458886456266471756471406475546466770.14
215.286514626513326513970.02
单位质量响应值RSD%判断
42488.6342630.690.24数据可信
供试品溶液-5122901批-厄贝沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173057-7305710.29910.1932.4810.3010.1932.48
279003-7900311.13811.14
359092-590928.3318.33
440595-405955.7235.72
5111386-11138615.70315.70
670650-706509.9609.96
10min1266410-26641037.55836.4511.2837.6736.5711.35
2264038-26403837.22437.35
3239807-23980733.80833.90
4212971-21297130.02430.09
5298705-29870542.11142.29
6269497-26949737.99338.10
15min1413967-41396758.36156.842.4458.8957.362.54
2397907-39790756.09756.63
3399929-39992956.38256.85
4389828-38982854.95855.35
5415323-41532358.55259.19
6402164-40216456.69757.23
20min1468413-46841366.03666.751.7967.2267.901.84
2464470-46447065.48066.64
3470910-47091066.38867.48
4471622-47162266.48967.50
5488558-48855868.87670.17
6476881-47688167.23068.39
30min1540173-54017376.15378.421.8578.0780.321.87
2553626-55362678.05079.94
3554013-55401378.10479.94
4557558-55755878.60480.35
5571655-57165580.59182.65
6560547-56054779.02580.94
45min1588577-58857782.97784.881.6985.7487.641.62
2596534-59653484.09986.85
3597661-59766184.25886.96
4617880-61788087.10889.73
5607206-60720685.60388.56
6604675-60467585.24688.03
60min1626145-62614588.27388.780.5891.9692.480.58
2626478-62647888.32092.01
3627800-62780088.50792.14
4634958-63495889.51693.10
5632989-63298989.23893.14
6629964-62996488.81292.55
90min1648267-64826791.39292.661.5196.0597.351.49
2645631-64563191.02095.69
3655606-65560692.42797.05
4665735-66573593.85598.44
5671331-67133194.64499.54
6657004-65700492.62497.35
120min1649555-64955591.57492.771.0597.2598.490.98
2650313-65031391.68097.36
3661767-66176793.29598.94
4666473-66647393.95999.58
5657994-65799492.76398.71
6662246-66224693.36399.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1649660-64966091.58892.731.0698.2899.480.95
2659313-65931392.94999.65
3655241-65524192.37599.06
4668752-66875294.280100.95
5652037-65203791.92398.90
6661364-66136493.238100.03
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.266307663023629836306562969630230.08
210.296375963732637460.03
单位质量响应值RSD%判断
6142.596194.950.61数据可信
供试品溶液-5123001批-非奈利酮-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12673-26733.8979.3373.373.909.3373.37
23101-31014.5214.52
315431-1543122.49622.50
46877-687710.02510.03
54618-46186.7326.73
65701-57018.3118.31
10min131228-3122845.52551.9311.5145.5752.0411.62
231488-3148845.90445.95
342037-4203761.28261.53
436618-3661853.38253.49
534644-3464450.50550.58
637731-3773155.00555.10
15min146312-4631267.51568.652.9568.0669.333.11
246294-4629467.48868.05
349814-4981472.62073.55
446518-4651867.81568.52
546313-4631367.51668.15
647283-4728368.93069.63
20min150849-5084974.12975.731.7375.4377.171.83
252723-5272376.86178.17
353211-5321177.57279.31
451316-5131674.81076.27
551507-5150775.08876.47
652060-5206075.89477.36
30min155943-5594381.55583.021.9883.6885.302.04
258078-5807884.66786.83
358201-5820184.84787.45
457299-5729983.53285.82
555433-5543380.81183.03
656715-5671582.68084.99
45min160062-6006287.56089.311.4590.5992.521.54
262035-6203590.43693.54
362399-6239990.96794.51
460966-6096688.87892.09
560610-6061088.35991.48
661493-6149389.64692.88
60min163497-6349792.56792.371.5096.5796.571.49
264642-6464294.23698.35
364214-6421493.61398.17
462132-6213290.57794.78
562721-6272191.43695.54
662965-6296591.79296.02
90min162596-6259691.25493.912.4696.2899.132.41
266890-6689097.514102.67
365108-6510894.916100.51
463529-6352992.61497.83
563277-6327792.24797.36
665098-6509894.901100.15
120min164646-6464694.24294.851.65100.29101.121.56
267071-6707197.778104.02
364852-6485294.543101.19
463862-6386293.09999.34
564975-6497594.722100.86
664951-6495194.687100.99
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限163411-6341192.44294.001.9099.53101.321.87
266217-6621796.533103.86
364754-6475494.400102.10
464288-6428893.720101.00
562896-6289691.69198.88
665294-6529495.187102.54
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.226477886479136486036475196478126479270.07
215.286561866565416563640.04
单位质量响应值RSD%判断
42570.7642955.760.64数据可信
供试品溶液-5123001批-厄贝沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146059-460596.46310.7921.996.4610.8021.99
285866-8586612.04812.05
394010-9401013.19113.19
472106-7210610.11710.12
577582-7758210.88610.89
685974-8597412.06312.06
10min1254051-25405135.64640.5011.4935.7240.6211.50
2274373-27437338.49738.63
3348719-34871948.92949.08
4283414-28341439.76639.88
5270809-27080937.99738.12
6300363-30036342.14442.28
15min1408746-40874657.35158.383.6457.8258.953.71
2411582-41158257.74958.31
3444976-44497662.43563.12
4405296-40529656.86757.42
5405945-40594556.95857.50
6420131-42013158.94959.55
20min1470463-47046366.01167.392.5467.1268.602.62
2483242-48324267.80469.01
3500513-50051370.22771.61
4470544-47054466.02267.21
5470557-47055766.02467.20
6486237-48623768.22469.48
30min1541766-54176676.01577.631.8077.8579.601.89
2556475-55647578.07980.04
3569340-56934079.88482.05
4551285-55128577.35179.27
5544497-54449776.39878.31
6556438-55643878.07480.09
45min1603213-60321384.63785.961.7887.3288.791.86
2610376-61037685.64288.47
3628493-62849388.18491.24
4606308-60630885.07187.85
5603610-60361084.69387.45
6623834-62383487.53090.41
60min1644661-64466190.45390.101.5794.0893.881.62
2641775-64177590.04893.82
3655717-65571792.00496.04
4628361-62836188.16591.89
5633367-63336788.86892.57
6648862-64886291.04294.90
90min1641112-64111289.95592.402.3994.5897.182.41
2667861-66786193.70898.48
3674130-67413094.58799.64
4650174-65017491.22695.93
5642675-64267590.17494.86
6675302-67530294.75299.62
120min1665003-66500393.30793.401.2198.9399.211.27
2670136-67013694.02799.84
3671450-67145094.211100.32
4653091-65309191.63597.35
5659911-65991192.59298.28
6674471-67447194.635100.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1652653-65265391.57492.581.9898.2499.431.99
2662072-66207292.89599.76
3669764-66976493.975101.13
4658742-65874292.42899.16
5639336-63933689.70596.42
6676291-67629194.891101.86
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